Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K192259
    Device Name
    Philips IntelliSite Pathology Solution
    Manufacturer
    Philips Electronics Nederland B.V.
    Date Cleared
    2019-09-20

    (30 days)

    Product Code
    PSY
    Regulation Number
    864.3700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Philips Electronics Nederland B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, viewing, and management system. The PIPS is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The PIPS is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. The PIPS comprises the Image Management System (IMS), the Ultra Fast Scanner (UFS) and display. The PIPS is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using PIPS.
    Device Description
    Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, viewing, and management system. PIPS consists of two sub-systems and a display component: - . Image Management System (IMS) - Ultra Fast Scanner (UFS) - . Display
    Ask a Question
    K Number
    K171055
    Device Name
    Philips BlueControl
    Manufacturer
    Philips Electronics Nederland B.V.
    Date Cleared
    2017-07-06

    (87 days)

    Product Code
    ONE
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Philips Electronics Nederland B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Philips BlueControl is intended to emit energy in the blue region of the spectrum, is generally indicated to treat dermatological conditions and specifically indicated to treat mild psoriasis vulgaris.
    Device Description
    The Philips BlueControl is a rechargeable battery-operated, wearable device for delivery of blue light to treat mild psoriasis vulgaris. It is a prescription device designed for home use. The Philips BlueControl is sold as a kit, which contains the following items: Components: o BlueControl Device o Fixation Strap (Device Holder and Slings) o Power Supply (USB Cable, Adapter and Charger) Accessory: ● 0 Carrying Case Instructions for Use.
    Ask a Question

    Page 1 of 1